Apparatus for forming a shaped film product

ABSTRACT

A process capable of commercial scale manufacturing of inexpensive, shaped film products includes placing a mask over a substrate; delivering a film-forming composition through a nozzle to form a raw shape on the substrate; removing the mask; and solidifying the film-forming composition to provide the shaped film product disposed on the substrate. The mask has a delivery surface and an opposite substrate-facing surface and at least one aperture having a design corresponding to the desired shaped film product. The nozzle is disposed in sealing engagement with the delivery surface of the mask to the at least one aperture of the mask during delivery of the film-forming composition.

This application is a divisional of Ser. No. 14/581,010 filed on Dec.23, 2014, and claims the benefit of provisional 61/922,306 filed on Dec.31, 2013, the complete disclosure of which is hereby incorporated hereinby reference for all purposes.

BACKGROUND

Film products have a wide variety of uses. These include decorativewindow decals, plasters, adhesive bandages, and oral strips (bothmedicated and otherwise).

Conventional production of such integral film products generallyinvolves die-cutting the desired shaped product from film stock. Whilethis production produces inexpensive film stock, die-cutting limits theefficiency and/or variability of final product forming. If the productshape is not completely rectangular or otherwise completely tessellated,the surrounding ladder scrap can produce significant waste. Therefore,products that have costly raw materials are often restricted to squareor other completely tessellated shapes to substantially eliminate thisexpensive waste. This unfortunately prevents the formation of optimalshapes for some uses. Examples of die-cutting medical films include suchproduction techniques are described in Pharmedica Ltd., WO 2012104834A1, Pinna et al, U.S. Pat. No. 7,612,048 B2, and Smithkline BeechamCorp., WO 2005/009386 A2.

On the other hand, printing—including stencil printing and screenprinting—are known processes that are capable of providing irregularshapes on substrates. Generally, the printed materials remain onpermanently joined to the substrates, such as printed text and graphicson paper, printed circuits in the electronics industry, and printeddesigns on clothing and signage. However, such integration of a carryingsubstrate into a printed element prevents the usage of the printedproduct separate from the substrate.

What is needed is a process capable of commercial scale manufacturing ofinexpensive, film products without the waste of die-cutting and whichproducts are capable of use independent of a supporting structure onwhich they are formed.

SUMMARY

Surprisingly, we have found a process capable of commercial scalemanufacturing of inexpensive, shaped film products without the waste ofdie-cutting. The process includes placing a mask over a substrate;delivering a film-forming composition through a nozzle to form a rawshape on the substrate; removing the mask; and solidifying thefilm-forming composition to provide the shaped film product disposed onthe substrate. The mask has a delivery surface and an oppositesubstrate-facing surface and at least one aperture having a designcorresponding to the desired shaped film product. The nozzle is disposedin sealing engagement with the delivery surface of the mask to the atleast one aperture of the mask during delivery of the film-formingcomposition.

In an alternative embodiment, a process includes placing a first maskover a substrate; delivering a first film-forming composition through anozzle to form a first raw shape on the substrate; removing the firstmask; placing a second mask over the first raw shape; controllingdelivery of a second film-forming composition to a void volume definedby a projection of a delivery opening of a nozzle, substrate and masksidewalls and delivering the controlled volume of the secondfilm-forming composition to the second mask aperture; removing thesecond mask; and solidifying the first and second raw shapes to providethe shaped film product disposed on the substrate. The first mask has adelivery surface and an opposite substrate-facing surface and at leastone aperture having a design corresponding to a desired shape of a firstlayer of the shaped film product, and the nozzle is placed in contactwith the delivery surface through the at least one aperture of the mask.The second mask has a delivery surface and an opposite substrate-facingsurface and at least one aperture having a design corresponding to thedesired shape of a second layer of the shaped film product.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a block diagram of a process according to one embodiment ofthe present invention.

FIG. 2 is a perspective view of a shaped film product according to anembodiment of the present invention.

FIG. 3 is perspective view of a flatbed printing apparatus useful in oneembodiment of the present invention.

FIG. 4 is cross section of the apparatus of FIG. 3.

FIG. 5A is a graph of the displacement of a piston in the bore of thepositive displacement pump of FIG. 3.

FIG. 5B is a plan view of a mask correlated to the displacement of thepiston in the bore of the positive displacement pump of FIG. 3.

FIG. 6 is perspective view of a rotary printing system useful in analternate embodiment of the present invention.

FIG. 7A is a bottom plan view of a multicomponent shaped film productaccording to an alternate embodiment of the invention.

FIG. 7B is a cross-section of the multilayer film product of FIG. 7Aalong line 7-7.

FIG. 8 is a perspective view of a step in the formation of themulticomponent shaped film product of FIG. 7A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to a process and apparatus for formingshaped film products. The following description is presented to enableone of ordinary skill in the art to make and use the invention. Variousmodifications to the embodiments and the generic principles and featuresdescribed herein will be readily apparent to those skilled in the art.Thus, the present invention is not intended to be limited to theembodiments shown but is to be accorded the widest scope consistent withthe principles and features described herein. Shaped film products mayhave a wide variety of uses. These include household and recreationaluses, such as decorative decals for windows and walls, temporary tattoos(such as body decals), healthcare devices such as medicated and/orabsorbent plasters, adhesive bandages and other wound coverings, oralstrips also known as a “consumable film” (medicated, therapeutic, andcosmetic), other body strips, such as moisturizing, acne treatment,lightening of dark circles, melisma, cellulite, delivery of vitamins,treatment of eczema, psoriasis, and the like.

As used herein the specification and the claims, the term “integral filmproduct” variants thereof relate to a film product that is sufficientlyrobust to permit handling for a desired purpose separate from anysupporting substrate. The product is removable from a substrate for useindependent of the substrate.

As used herein the specification and the claims, the term “film-formingcomposition” variants thereof relate to a composition that is capable offorming, by itself or in the presence of an additional agent, acontinuous film on a substrate.

As used herein the specification and the claims, the term “raw shape”variants thereof relate to the shaped volume of film-forming compositiondisposed on a substrate through an apertured mask. The raw shapegenerally requires further processing, such as integration, to transformit into an integral film product.

As used herein the specification and the claims, the term “multilayeredshaped film product” and variants thereof relate to thin products withtwo or more distinct layers (not mixed or homogeneous. Products withlayers containing different characteristics such as: adhesion, flavor,color, texture, etc. Layers may be continuous, intermittent, oradjacent.

As used herein the specification and the claims, the term “tessellated”and variants thereof relate to a planar surface having a pattern of flatshapes having no overlaps or gaps. Thus, there is no “ladder wastebetween the shapes.

Referring to the drawing, FIG. 1 is a high level flow chart of a processfor forming multilayered shaped film products. A first Step 10 includesforming a mask having an aperture. A second Step 20 includes placing themask over a substrate. A third Step 30 includes delivering a liquid,film-forming composition through the mask to the substrate to form a rawshape. A fourth Step 40 includes removing the mask. A fifth Step 50includes solidifying the raw shape to form the shaped film product.

A shaped film product 100 according to one embodiment of the inventionis shown in FIG. 2. In this embodiment, the shaped film product 100 hasa variable width measured perpendicular to a longitudinal axis x-x, andthe product is narrow at a first end 102, increases to a maximum width,and terminates with a rounded second end 104, opposite the first end102.

As shown in FIG. 2, the innovations of the present invention allow theshape to be as simple or complex as desired. In one advantage of thepresent invention, the shape can be relatively complex—the kind of shapethat would produce excessive ladder waste in a die-cutting operation.For example, the minimum ladder waste produced during the printing of apattern of nested circles is about 20% (based on circles arranged instraight columns and rows touching at the quadrants).

In reference to the embodiment of FIG. 2, Step 10 involves forming amask having at least one aperture corresponding to a raw shape.

Print masks are known in the art. They can include without limitationstencils, tapes, and the like. While the exact fabrication of the printmasks is not critical to the present invention, our invention makes ispossible to form relatively thick integral film products and therefore,use relatively thick masks. Preferably, the mask has a thickness of atleast about 0.05 millimeters (“mm”). In one embodiment for use on theskin for flexible, relatively unnoticeable products, the mask has athickness of between about 0.05 mm and about 0.3 mm, more preferably,between about 0.1 and about 0.2 mm. In another embodiment, thickintegral film products can be made using a mask having a thickness ofgreater than about 0.2 mm, preferably between about 0.2 and about 2 mm,preferably between about 0.4 mm and about 1 mm, and most preferablybetween about 0.5 mm and about 1 mm. In many embodiments, the thicknessof the mask is not critical, while in other embodiments, the presentinvention makes possible the formation of integral film products withpreviously unknown thicknesses.

The thickness of the mask generally determines the maximum thickness ofthe integral film product. The relationship is determined by the natureof the film-forming composition and the mechanism by which thecomposition solidifies. For example, hot melt and hydrocolloidfilm-forming compositions generally produce a product thickness that isessentially equivalent to the mask thickness. Foaming film-formingcompositions can also be used and may provide solidified films having athickness substantially equivalent to the thickness of the mask, orpossibly even thicker. Solvent or other carrier-based compositions willlose thickness as the product solidifies. The reduction in thickness isgenerally related to the solids content of the composition. We havefound that a solids content of 30-40% delivers an integral film producthaving a thickness of about 50% of the mask thickness. Formulations withlower solids content would likely deliver final products having athickness of even less than 50% of the mask thickness.

For example, a stencil mask thickness of 0.5 mm would be capable ofdepositing a raw shape of film-forming composition of about 0.5 mm. Upontransformation into the integral film product, the thickness woulddiminish, based upon the solids content of the film-forming composition.

The choice of materials is not critical in the production of the printmasks of the present invention. Those of ordinary skill in the art willrecognize that masks can be made of structural materials, includingwithout limitation: metals, such as aluminum alloy, stainless steel, Nialloy, Cr alloy or the like; resins, such mask as polyimide, polyester,epoxy, polycarbonate, polyethylene, polyethylene terephthalate (PET),polypropylene or the like; glass; paper; wood; or cardboard, as well ascombination thereof. As another example, the mask body may be made of acomposite material, such as glass fiber filled polyimides, polyesters,or epoxies. The mask body is formed in a sheet from these materials. Thethickness of the sheet may be from 20 to 2000 microns (μm), although forease in handling and other considerations, the thickness is preferablyfrom 20 to 80 μm.

In a preferred embodiment, the mask has a uniform thickness. However, itis possible to employ a mask having a thickness that changes along themachine direction. For example, the mask may have a thickened centralportion along the machine direction and tapered ends.

An example of a mask according to one embodiment of the presentinvention, useful in the formation of the shaped film product 100 ofFIG. 2 is a mask 200 that may be used in the flatbed printing apparatusshown in FIG. 3. The mask 200 includes an impermeable mask portion 202which defines at least one aperture 204. The mask 200 is placed over asubstrate 206 in Step 20. This substrate 206 may be an endless belt (acontinuous flexible web, linked platens, and the like), or it may be aweb that carries the resulting shaped product. The shaped product may bepermanently attached to the web, or it may be releasably attached to aweb, such as a release liner. Surfaces may be modified through the useof dry film lubricants such as molybdenum disulfide, graphite, tungstendisulfide or oils that are generally known to those of ordinary skill inthe art. Typical release surfaces may include silicone,polytetrafluoroethylene (PTFE), waxes, polymers, polished metals, orcombinations thereof. The process may employ flatbed apparatus or rotaryapparatus. The printing apparatus will have a support 208 for thesubstrate 206 and system for delivering a film-forming compositionthrough the mask aperture 204 (Step 30). The system includes afilm-forming composition reservoir (not shown), a nozzle 210, a pump212, and a pump controller (such as a cam 214).

The system for delivering the film-forming composition interacts withthe mask 200 to provide appropriate volume of film-forming compositionto the mask to accurately fill the void volume in the mask aperture 204below the nozzle 210 during relative motion between the mask and nozzle.This relative motion (shown in FIGS. 3 and 4 as arrow 216) defines amachine direction.

Referring to FIG. 4, the system includes a nozzle 210 arranged andconfigured bear against an upper surface 218 of the mask 200. The lowersurface 220 of the mask 200 is in contact with the substrate 206. If thenozzle applies sufficient force against the substrate and mask, it willform a seal with the upper surface of the mask and between the lowersurface and the substrate effective to minimize leakage of film-formingcomposition 222. The nozzle 210 has a delivery opening 224 defining amachine direction dimension and a cross-direction dimension. Preferably,the cross-direction dimension is greater than the maximumcross-direction dimension of the at least one aperture 204 formed in themask 200, however, in some embodiments of the invention, thecross-direction dimension of the nozzle is equal to or slightly lessthan the maximum cross-direction dimension of the at least one aperture.Thus, the substrate 206, mask sidewalls 226 and the projection of thedelivery opening 224 of the nozzle 210 define a void volume 228 when thenozzle is disposed over at least a portion of the mask aperture 204, andthe pump is controlled to output a volume of the film-formingcomposition 222 to the delivery opening 224 corresponding to that voidvolume over which the delivery opening 224 is located. This void volumecan change during the relative motion between the nozzle 210 and mask200, so the volume of the film-forming composition output to thedelivery opening 224 will change with the changing void volume. Theoutput of the pump 212 can be controlled through control means known tothose of ordinary skill in the art. In an example shown in FIG. 3, themask 200 can be placed in proximity to a cam 214 that is coupled to apiston pump form of a positive displacement pump 212. In thisarrangement, the nozzle 210 is movable across the upper surface 218 ofthe mask 200 defining the mask aperture 204. The nozzle 210 is connectedto a positive displacement pump 212 having a cavity or bore containingthe film-forming composition 222. As the nozzle 210 reaches the maskaperture 204 a cam follower 230 engages the cam 214. The cam profilecorrelates to the void volume defined by the substrate 206, masksidewalls 226 and delivery opening 224 of the nozzle 210, as describedabove. As the nozzle 210 moves along the mask 200, the cam 214determines the motion of the cam follower 230 to move a piston in thebore of the pump to output a volume of film-forming material 222corresponding to the void volume adjacent the delivery opening 224 ofthe nozzle 210. Because the output volumetric flow of the positivedisplacement pump 212 corresponds to the changing void volume as thenozzle 210 moves along the mask 200, there is minimal disturbance tofluid flow. Preferably, the flow is substantially laminar from thedelivery opening to the substrate. When the delivery opening 224 of thenozzle 210 reaches the end of the mask aperture 204, the pump outputterminates, and the film-forming composition delivery system may then beremoved from the mask. The delivery opening 224 may have any shapeappropriate for delivering the film-forming composition. A particularlypreferred delivery opening is a rectangular slot having across-direction dimension that is substantially greater than the machinedirection dimension.

Using a rectangular slot nozzle, the cam displacement for ateardrop-shaped film product having a raw shape thickness of about 0.75mm is shown in FIGS. 5A and 5B. FIG. 5A shows a graph of thedisplacement of the cam follower 230 that is coupled to a piston havinga ½ inch diameter in the bore of the positive displacement pump 212 ofFIG. 3. FIG. 5B is a plan view of a mask 200 correlated to thedisplacement of the cam follower 230 caused by movement along the cam214 in the direction shown in FIG. 4. A comparison of FIGS. 5A and 5Bshows that no film-forming composition is provided to the mask apertureuntil the nozzle reaches the left edge of the mask aperture. Thus, theslope of the displacement line 232 is zero at the right edge of thegraph of FIG. 5A. The volumetric flow rate increases as the aperturewidth increases (shown by the greater slope of displacement line 232 ofFIG. 5A). Once the maximum width of the mask aperture is reached near avalue of about 20 on the x-axis of FIG. 5A, the volumetric flow ratedecreases to zero at the right edge of the mask aperture.

While the above process is described with respect to a cam systemcontrolling a positive displacement pump, it is evident that alternativevolumetric pumps and volumetric flow controllers may be used andcorrelated to the relative motion of the nozzle and mask aperture. Forexample, computer controlled volumetric pumps can vary the fluiddispense rate to portions of the mask aperture to provide the volume offilm-forming composition corresponding to the void volume. Additional,non-limiting representative examples of such pumps and controls includerotary pumps (such as gear, screw, peristaltic, and flexible impeller)and reciprocating pumps (such as piston and diaphragm), and the like.

In step 40, the first mask 200 is removed leaving a first raw shapedeposited on the substrate 206. The faster the mask is removed, thebetter the definition and edge quality of the raw shape and resultingfilm product. Thus, a rotary stencil generally delivers a superiorquality shaped film product.

In step 50, the raw shape 234 is solidified into the shaped film product100. Again, the shaped film product 100 may be permanently attached tothe substrate 206, or the substrate 206 may be a release liner to permitthe product to be removed therefrom for use independent of thesubstrate. The exact nature of the solidifying station is not criticalto the present invention. For example, the raw shape may be heated todrive off volatile carriers, such as such as water and organic solvents.Alternately, the solidifying can be through providing energy, such as UVlight to cross-link or otherwise “cure” one or more polymericfilm-forming components. If one or more film-forming components is ahotmelt composition, the solidifying can be as simple as allowing theraw shape to cool below a melt or glass transition temperature.

One of ordinary skill in the art will recognize that additional layersmay be added by repeating steps 20 through 40 with additionalfilm-forming compositions to provide multilayered film products (withoutsolidification between film layer formation) having at least two layers.The present invention is particularly suited to apply raw shapes inlayers as there is minimal disturbance to fluid flow with the correlatedvolumetric output of the pump, as described above. Again, multiplelayers formed on raw, unsolidified layers are possible, because thedelivery of subsequent layers occurs with substantially laminar flow.This minimizes mixing of adjacent film-forming compositions. Accuratecontrol of the nozzle output avoids layer mixing at the point ofapplication.

Again, the shaped film product may be permanently attached to the web,or it may be releasably attached to a web, such as a release liner. Ifthe process according to the present invention employs a release linedweb as the substrate, the release lined web may be used as a carrier andpackaged with the shaped film product in appropriate sized primarypackaging until delivered to a consumer. The consumer may then removethe shaped film product from the substrate and use it as desired.Alternately, if the process according to the present invention employsan endless belt having a releasable surface or other substrateintegrated into the manufacturing equipment, the shaped film product isremoved from the releasable surface of the substrate and packaged fordelivery to a consumer. The shaped film product may have an adhesivesurface, such as in a medicated plaster, or it may have non-tackysurfaces, such as in an oral strip.

The above processes are described with reference to flatbed stencilprinting systems. However, one of ordinary skill in the art willrecognize that variations may be made to the process. For example, arotary printing system 300 shown in FIG. 6 may be used. In this system,the film-forming composition is applied with a nozzle 302. A printingdrum 304 includes a plurality of mask apertures 306. The rotation of thedrum 304 indexes a mask aperture 306 to the nozzle 302. A controller,such one or more elements to identify and read mask aperture position,correlates the controlled volumetric delivery of film-formingcomposition to the delivery opening of the nozzle (as described above).The film-forming composition is delivered to the interior of the drum304 via a conduit from a reservoir (not shown) void volume defined bythe nozzle 302, mask sidewalls 308 and substrate 310, again, asdescribed above. The raw shape 312 then moves in the direction of arrow314 for further processing.

The following technical considerations are believed to be relevant tostencil printing via a film-forming composition delivery nozzle.Accurate dispensing of the film-forming composition leads to successfulaccurate shape formation. This is achieved when the instantaneous volumeof the film-forming composition dispensed equals the immediatelyadjacent and corresponding stencil volume. In the undesirable event ofdispensing excess film-forming composition, the excess collects on theleading edge of the slot nozzle. This accumulation can spilluncontrollably through the next stencil opening and contaminate theexterior surface of the stencil. This creates defects such as poor edgedefinition and smears between patterns. Under filling of the maskaperture leads to product defects such as skips and voids. The slotnozzle opening (width) generally equals the maximum pattern width.Pressing the nozzle against the stencil surface creates a dynamic seal.Hence, the effective nozzle width naturally changes as the stencilopening passes across the nozzle.

Capillary action can draw the liquid film-forming composition intonarrow gaps. Stenciling in a flat plane works best with the quickremoval of the stencil from the substrate to avoid liquid wickingbetween. Capillary action can create defects such as feathered and roughedges. Rotary stenciling (stencil in a cylinder form) minimizes theeffects of capillary action, because stencil contact with the substrateis along a line tangent to the cylindrical. Increasing web (substrate)speed can improve this further.

Print thickness is controlled by mask thickness (and the correspondingliquid flow). The minimum mask thickness is a material strength issue.Stainless steel 0.006 inch thick may be a practical lower limit withcurrent technology. 0.006 thick mask yields dry film thicknesses in therange of 0.002-0.003 inch depending upon liquid solids content.

Island stencil printing offers special challenges due to the aboveconsiderations. Stencil printing of a multicomponent shaped film product700 having an island 702 surrounded by another film material 704 (suchas shown in FIGS. 7A and B) according to the present invention takesadvantage of the laminar flow of the film-forming composition duringprinting. The “film material(s)” are the result of the transformation ofthe film-forming composition(s) into a film structure. This also avoidsmixing between layers. In order to form a stencil-printed “island”product 700, the island portion 702 of the product can be formed on thesubstrate 800 as an initial step (as shown in FIG. 8). This initial stepcan be performed via stencil printing as described above, or it can beformed otherwise, such as via screen printing, and other processes knowto those of ordinary skill in the art. Next, a mask 802 is placed aboutthe “island”, and the aperture of the mask is filled with a film-formingcomposition as described above (see FIGS. 3 and 4), however, thedispensing flow rate must account for the island volume. Whencalculating the instantaneous dispense rate the island volume would besubtracted from the total volume. It is also important that the shape ofthe island corresponds to or fits within the mask aperture and has aheight h_(i) that is less than the thickness of the mask h_(m). Again,accurate flow rate of the film-forming composition is important to avoidsmearing and or mixing of the island layer by the subsequently added toplayer.

We have also found that it is preferred to have an island film-formingcomposition viscosity higher than the second film-forming compositionviscosity. The higher viscosity will better resist sheer forces anddiscourage mixing.

The film-forming compositions employed in the present invention may bein the form of a hotmelt composition, a solid material that can bemelted to form a flowable liquid and deposited to form a raw shape whichcan then cool to form the integral film product. Alternatively, thefilm-forming composition may include at least a film forming componentand a carrier. Additional components may include, without limitation,emulsifiers, surfactants, plasticizers, active ingredients, fragrances,coloring agents, flavorings, and other components known to those ofordinary skill in the art. The carrier is preferably a liquid and may bea solvent or diluent. Preferred carriers include water and alcohols.

The water soluble polymers of the present invention possess film formingproperties useful producing the films of the present invention. Manywater soluble polymers may be used in the films of the presentinvention. A representative, non-limiting list includes pullulan,cellulose ethers (such as hydroxypropylmethyl cellulose, hydroxyethylcellulose, hydroxypropyl cellulose), polyvinyl pyrrolidone,carboxymethyl cellulose, polyvinyl alcohol, sodium alginate,polyethylene glycol, tragacanth gum, guar gum, acacia gum, arabic gum,polyacrylic acid, methylmethacrylate copolymers, carboxyvinyl polymers,amylose, starches (such as high amylose starch and hydroxypropylatedhigh amylose starch), dextrin, pectin, chitin, chitosan, levan, elsinan,collagen, gelatin, zein, gluten, soy protein isolate, whey proteinisolate, casein and/or mixtures thereof.

In one preferred embodiment, the carrier is water. In alternateembodiments, organic solvents which have been conventionally used can beemployed as the solvent. A representative, non-limiting list of usefulsolvents includes monovalent alcohols such as methanol, ethanol,propanol, butanol, 3-methoxy-3-methyl-1-butanol, and3-methoxy-1-butanol; alkylcarboxylic acid esters such asmethyl-3-methoxypropionate, and ethyl-3-ethoxypropionate; polyhydricalcohols such as ethylene glycol, diethylene glycol, and propyleneglycol; polyhydric alcohol derivatives such as ethylene glycolmonomethyl ether, ethylene glycol monoethyl ether, ethylene glycolmonopropyl ether, ethylene glycol monobutyl ether, propylene glycolmonomethyl ether, propylene glycol monoethyl ether, propylene glycolmonopropyl ether, propylene glycol monobutyl ether, ethylene glycolmonomethyl ether acetate, ethylene glycol monoethyl ether acetate, andpropylene glycol monomethyl ether acetate; fatty acids such as aceticacid, and propionic acid; ketone such as acetone, methyl ethyl ketone,and 2-heptanone. These organic solvents may be used alone, or incombination.

The film product may also contain at least one surfactant, includinganionic, amphoteric, non-ionic, and cationic surfactants or mixturesthereof.

A representative, non-limiting list of anionic surfactants includes,alone or mixed, salts (for example salts of alkali metals, such as ofsodium, ammonium salts, salts of amines, salts of amino-alcohols ormagnesium salts) of the following compounds: alkyl sulphates, alkylethersulphates, alkylamidoether-sulphates, alkylarylpolyether-sulphates,monoglyceride sulphates, alkyl sulphonates, alkyl phosphates, alkylamidesulphonates, alkaryl sulphonates, alpha-olefin sulphonates, paraffinsulphonates; alkyl sulphosuccinates, alkylether sulphosuccinates,alkylamide-sulphosuccinates, alkyl sulphosuccinamates, alkylsulphoacetates, alkylether phosphates, acyl sarcosinates, acylisethionates and N-acyl taurates, the alkyl or acyl radical of all thesevarious compounds for example having from 8 to 24 carbon atoms, and anaryl radical such as a phenyl or benzyl group.

According to at least one embodiment, the salts include those of fattyacids, such as the salts of oleic, ricinoleic, palmitic, stearic acids,acids of copra oil or of hydrogenated copra oil, acyl lactylates whoseacyl radical has 8 to 20 carbon atoms, alkyl D-galactoside uronic acidsand their salts as well as the polyoxyalkylenated alkyl(C6-C24)ethercarboxylic acids, the polyoxyalkylenated alkyl(C6-C24)aryl ethercarboxylic acids, the polyoxyalkylenated alkyl(C6-C24)amido-ethercarboxylic acids and their salts, for example those having from 2 to 50ethylene oxide groups, and mixtures thereof.

A representative, non-limiting list of amphoteric surfactants includes,alone or mixed, the derivatives of secondary or tertiary aliphaticamines wherein the aliphatic radical is a linear and branched chain with8 to 22 carbon atoms and comprises at least one hydrosolubilizinganionic group (for example carboxylate, sulphonate, sulphate, phosphateor phosphonate); the alkyl (C8-C20) betaines, the sulphobetaines, thealkyl (C8-C20) amidoalkyl (C1-C6) betaines such as cocoamidopropylbetaine or the alkyl (C8-C20) amidoalkyl (C1-C6) sulphobetaines.

A representative, non-limiting list of non-ionic surfactants includes,alone or mixed, alcohols, alpha-diols, alkyl phenols or polyethoxylated,polypropoxylated or polyglycerolated fatty acids, having an aliphaticchain with for example 8 to 18 carbon atoms, where the number ofethylene oxide or propylene oxide groups can optionally be in the rangefrom 2 to 50 and the number of glycerol groups can optionally be in therange from 2 to 30.

Any plasticizer known in the pharmaceutical art is suitable for use inthe film product. These include, but are not limited to, polyethyleneglycol; glycerin; sorbitol; triethyl citrate; tribuyl citrate; dibutylsebecate; vegetable oils such as castor oil; surfactants such aspolysorbates, sodium lauryl sulfates, and dioctyl-sodiumsulfosuccinates; propylene glycol; mono acetate of glycerol; diacetateof glycerol; triacetate of glycerol; natural gums and mixtures thereof.

The film product of the present invention may also contain at least onecolorant, such as a pigment or dyestuff. Examples of suitable pigmentsinclude, but are not limited to, inorganic pigments, organic pigments,lakes, pearlescent pigments, irridescent or optically variable pigments,and mixtures thereof. A pigment should be understood to mean inorganicor organic, white or colored particles. Said pigments may optionally besurface-treated within the scope of the present invention but are notlimited to treatments such as silicones, perfluorinated compounds,lecithin, and amino acids.

Representative examples of inorganic pigments useful in the presentinvention include those selected from the group consisting of rutile oranatase titanium dioxide, coded in the Color Index under the referenceCI 77,891; black, yellow, red and brown iron oxides, coded underreferences CI 77,499, 77,492 and, 77,491; manganese violet (CI 77,742);ultramarine blue (CI 77,007); chromium oxide (CI 77,288); chromiumhydrate (CI 77,289); and ferric blue (CI 77,510) and mixtures thereof.

Representative examples of organic pigments and lakes useful in thepresent invention include, but are not limited to, D&C Red No. 19 (CI45,170), D&C Red No. 9 (CI 15,585), D&C Red No. 21 (CI 45,380), D&COrange No. 4 (CI 15,510), D&C Orange No. 5 (CI 45,370), D&C Red No. 27(CI 45,410), D&C Red No. 13 (CI 15,630), D&C Red No. 7 (CI 15,850), D&CRed No. 6 (CI 15,850), D&C Yellow No. 5 (CI 19,140), D&C Red No. 36 (CI12,085), D&C Orange No. 10 (CI 45,425), D&C Yellow No. 6 (CI 15,985),D&C Red No. 30 (CI 73,360), D&C Red No. 3 (CI 45,430) and the dye orlakes based on cochineal carmine (CI 75,570) and mixtures thereof.

Representative examples of pearlescent pigments useful in the presentinvention include those selected from the group consisting of the whitepearlescent pigments such as mica coated with titanium oxide, micacoated with titanium dioxide, bismuth oxychloride, titanium oxychloride,colored pearlescent pigments such as titanium mica with iron oxides,titanium mica with ferric blue, chromium oxide and the like, titaniummica with an organic pigment of the above-mentioned type as well asthose based on bismuth oxychloride and mixtures thereof.

The precise amount and type of colorant employed in the cosmeticcompositions of the invention will depend on the color, intensity anduse of the cosmetic composition and, as a result, will be determined bythose skilled in the art of cosmetic formulation.

Any thickener known in the art may optionally be added to the film.Suitable thickeners include, but are not limited to, cyclodextrin,crystallizable carbohydrates, and the like, and derivatives andcombinations thereof. Suitable crystallizable carbohydrates include themonosaccharides and the oligosaccharides. Of the monosaccharides, thealdohexoses e.g., the D and L isomers of allose, altrose, glucose,mannose, gulose, idose, galactose, talose, and the ketohexoses e.g., theD and L isomers of fructose and sorbose along with their hydrogenatedanalogs: e.g., glucitol (sorbitol), and mannitol are preferred. Of theoligosaccharides, the 1,2-disaccharides sucrose and trehalose, the1,4-disaccharides maltose, lactose, and cellobiose, and the1,6-disaccharides gentiobiose and melibiose, as well as thetrisaccharide raffinose are preferred along with the isomerized form ofsucrose known as isomaltulose and its hydrogenated analog isomalt. Otherhydrogenated forms of reducing disaccharides (such as maltose andlactose), for example, maltitol and lactitol are also preferred.Additionally, the hydrogenated forms of the aldopentoses: e.g., D and Lribose, arabinose, xylose, and lyxose and the hydrogenated forms of thealdotetroses: e.g., D and L erythrose and threose are suitable and areexemplified by xylitol and erythritol, respectively.

Preservatives known in the art may optionally be added to the film.Suitable Preservatives include, but are not limited to BenzalkoniumChloride, Benzyl Alcohol, 2-Bromo-2-Nitropropane, Butylparaben,Chlorhexidine Digluconate, Chlorphenism, Dehydroacetic Acid, CitricAcid, Diazolidinyl Urea, DMDM Hydantoin, Ethylparaben, Formaldehyde,Imidazolidinyl Urea, Isobutylparaben, Methylisothiazolinone,Methylparaben, Phenoxyethanol, Polyaminopropyl biguanide, PotassiumSorbate, Propylparaben, Quaternium-15, Salicylic Acid, Sodium benzoate,Sodium Dehydroacetate, Sodium Metabisulfite, Sodium Salicylate, SodiumSulfite, Sorbic Acid, Stearalkonium Chloride, Triclosan, and ZincPyrithione.

In some embodiments, “microbeads” or other particulate materials may beincorporated and used as “scrubbing particles” or “exfoliates” in filmproducts used in personal care products such as facial scrubs and bodywashes. The microbeads are small particles, generally having a particlesize of less than about 1,000 μm, often less than about 750 μm. Often,topical compositions and/or skin cleansing compositions incorporatemicrobeads or particulates having a size of less than about 300 μm, andpreferably, less than about 100 μm. Particulates, such as pumice canrange from 35-1400 μm; topical compositions generally employ pumicehaving a particle size of about 100 μm. The microbeads can be agenerally homogeneous material and can comprise pumice, polyethylene,glass, aluminum oxide, titanium dioxide, celluloses, such asHydroxypropyl Methylcellulose (HPMC), or Vitamin E. Alternatively, themicrobeads can be in the form of microencapsulated particles in whichdesirable material is encapsulated in a covering material to delay therelease of the material to the environment. The microencapsulatedparticle may include adhesives and/or one or more benefit agentsdescribed in more detail below.

In a preferred embodiment, the film-forming composition, for example asshown in FIGS. 2 and 3, includes a benefit agent. The resulting shapedfilm product 100 has a first surface 106 formed on a releasable surfaceof the substrate, and a second surface 108 opposite thereof. The firstsurface 106 is arranged and configured to deliver the benefit agenttherethrough. For example, the first surface 106 may be protected by arelease liner on a flexible substrate during manufacture and storageprior to use by a consumer. On the other hand, the second surface 108 isexposed to ambient conditions during the finishing of the raw shape.Thus, the first surface 106 may be tacky after removal from thesubstrate, and it may adhere to the skin of a consumer. The secondsurface 108 may “dry out” during transformation to the shaped filmproduct 100. Thus, the tacky first surface 106 can be ideal for deliveryof a benefit agent to the skin of the consumer.

As used herein the specification and the claims, the term “benefitagent” and variants thereof relates to an element, an ion, a compound(e.g., a synthetic compound or a compound isolated from a naturalsource) or other chemical moiety in solid (e.g. particulate), liquid, orgaseous state and compound that has a cosmetic or therapeutic effect onthe skin.

The compositions of the present invention may further include one ormore benefit agents or pharmaceutically-acceptable salts and/or estersthereof, the benefit agents generally capable of interacting with theskin to provide a benefit thereto. As used herein, the term “benefitagent” includes any active ingredient that is to be delivered intoand/or onto the skin at a desired location, such as a cosmetic orpharmaceutical.

The benefit agents useful herein may be categorized by their therapeuticbenefit or their postulated mode of action. However, it is to beunderstood that the benefit agents useful herein may, in somecircumstances, provide more than one therapeutic benefit or operate viagreater than one mode of action. Therefore, the particularclassifications provided herein are made for the sake of convenience andare not intended to limit the benefit agents to the particularapplication(s) listed.

Examples of suitable benefit agents include those that provide benefitsto the skin, such as, but not limited to, depigmentation agents;reflectants; film forming polymers; amino acids and their derivatives;antimicrobial agents; allergy inhibitors; anti-acne agents; anti-agingagents; anti-wrinkling agents, antiseptics; analgesics; shine-controlagents; antipruritics; local anesthetics; anti-hair loss agents; hairgrowth promoting agents; hair growth inhibitor agents, antihistamines;anti-infectives; anti-inflammatory agents; anticholinergics;vasoconstrictors; vasodilators; wound healing promoters; peptides,polypeptides and proteins; deodorants and antiperspirants; medicamentagents; skin firming agents, vitamins; skin lightening agents; skindarkening agents; antifungals; depilating agents; counterirritants;hemorrhoidals; insecticides; enzymes for exfoliation or other functionalbenefits; enzyme inhibitors; poison ivy products; poison oak products;burn products; anti-diaper rash agents; prickly heat agents; vitamins;herbal extracts; vitamin A and its derivatives; flavenoids; sensates;anti-oxidants; hair lighteners, sunscreens; anti-edema agents,neo-collagen enhancers, film-forming polymers, chelating agents;anti-dandruff/sebhorreic dermatitis/psoriasis agents; keratolytics; andmixtures thereof.

In addition the benefit agent may also provide passive benefits to theskin. As such, the benefit agent may be formulated into a compositionthat include such ingredients as humectants or emollients, softeners orconditioners of the skin, make-up preparations, and mixtures thereof.

Examples of suitable anti-edema agents nonexclusively include bisabololnatural, synthetic bisabolol, corticosteroids, beta-glucans, andmixtures thereof.

Examples of suitable vasoconstrictors nonexclusively include horsechestnut extract, prickly ash, peroxides, tetrahydrozaline, and mixturesthereof.

Examples of suitable anti-inflammatory agents nonexclusively includebenoxaprofen, centella asiatica, bisabolol, feverfew (whole), feverfew(parthenolide free), green tea extract, green tea concentrate, hydrogenperoxide, salicylates, oat oil, chamomile, and mixtures thereof.

Examples of neo-collagen enhancers nonexclusively include vitamin A andits derivatives (e.g. beta-carotene and retinoids such as retinoic acid,retinal, retinyl esters such as and retinyl palmitate, retinyl acetateand retinyl propionate); vitamin C and its derivatives such as ascorbicacid, ascorbyl phosphates, ascorbyl palmitate and ascorbyl glucoside;copper peptides; simple sugars such as lactose, mellibiose and fructose;and mixtures thereof.

Examples of enzymes include papain, bromelain, pepsin, and trypsin.

Examples of suitable skin firming agent nonexclusively includealkanolamines such as dimethylaminoethanol (“DMAE”).

Examples of suitable antipruritics and skin protectants nonexclusivelyinclude oatmeal, beta-glucan, feverfew, soy products (by “soy product,”it is meant a substance derived from soybeans, as described in UnitedStates Patent Application 2002-0160062), bicarbonate of soda, colloidaloatmeal, Anagallis Arvensis, Oenothera Biennis, Verbena Officinalis, andthe like. As used herein, colloidal oatmeal means the powder resultingfrom the grinding and further processing of whole oat grain meetingUnited States Standards for Number 1 or Number 2 oats. The colloidaloatmeal has a particle size distribution as follows: not more than 3percent of the total particles exceed 150 micrometers in size and notmore than 20 percent of the total particles exceed 75 micrometers insize. Examples of suitable colloidal oatmeals include, but are notlimited to, “Tech-O” available from the Beacon Corporation (Kenilworth,N.J.) and colloidal oatmeals available from Quaker (Chicago, Ill.).

Examples of suitable reflectants nonexclusively include mica, alumina,calcium silicate, glycol dioleate, glycol distearate, silica, sodiummagnesium fluorosilicate, and mixtures thereof.

Examples of skin darkening agents nonexclusively include dihydroxyacetone, erythulose, melanin, and mixtures thereof.

Suitable film forming polymers include those that, upon drying, producea substantially continuous coating or film on the skin or nails.Nonexclusive examples of suitable film forming polymers includeacrylamidopropyl trimonium chloride/acrylamide copolymer; cornstarch/acrylamide/sodium acrylate copolymer; polyquaternium-10,polyquaternium-47; polyvinylmethylether/maleic anhydride copolymer;styrene/acrylates copolymers; and mixtures thereof.

Commercially available humectants which are capable of providingmoisturization and conditioning properties nonexclusively include: (i)water soluble liquid polyols selected from the group comprisingglycerine, propylene glycol, hexylene glycol, butylene glycol, pentyleneglycol, dipropylene glycol, and mixtures thereof; (ii) polyalkyleneglycol of the formula HO—(R″O)b-H wherein R″ is an alkylene group havingfrom about 2 to about 4 carbon atoms and b is an integer of from about 1to about 10, such as PEG 4; (iii) polyethylene glycol ether of methylglucose of formula CH3-C6H10O5-(OCH2CH2)c-OH wherein c is an integerfrom about 5 to about 25; (iv) urea; (v) fructose; (vi) glucose; (vii)honey; (viii) lactic acid; (ix) maltose; (x) sodium glucuronate; and(xi) mixtures thereof, with glycerine being an exemplary humectant.

Suitable amino acids and derivatives include amino acids derived fromthe hydrolysis of various proteins as well as the salts, esters, andacyl derivatives thereof. Examples of such amino acid agentsnonexclusively include amphoteric amino acids such as alkylamidoalkylamines, i.e. stearyl acetyl glutamate, capryloyl silk amino acid,capryloyl collagen amino acids; capryloyl keratin amino acids; capryloylpea amino acids; cocodimonium hydroxypropyl silk amino acids; corngluten amino acids; cysteine; glutamic acid; glycine; hair keratin aminoacids; amino acids such as aspartic acid, threonine, serine, glutamicacid, proline, glycine, alanine, cystine, valine, methionine,isoleucine, leucine, tyrosine, phenylalanine, cysteic acid, lysine,histidine, arginine, cysteine, tryptophan, citrulline; lysine; silkamino acids, wheat amino acids; and mixtures thereof.

Suitable proteins include those polymers that have a long chain, i.e. atleast about 10 carbon atoms, and a high molecular weight, i.e. at leastabout 1000, and are formed by self-condensation of amino acids.Nonexclusive examples of such proteins include collagen,deoxyribonuclease, iodized corn protein; milk protein; protease; serumprotein; silk; sweet almond protein; wheat germ protein; wheat protein;alpha and beta helix of keratin proteins; hair proteins, such asintermediate filament proteins, high-sulfur proteins, ultrahigh-sulfurproteins, intermediate filament-associated proteins, high-tyrosineproteins, high-glycine tyrosine proteins, tricohyalin, and mixturesthereof.

Examples of suitable vitamins nonexclusively include various forms ofvitamin B complex, including thiamine, nicotinic acid, biotin,pantothenic acid, choline, riboflavin, vitamin B3, vitamin B6, vitaminB12, pyridoxine, inositol, carnitine; vitamins A, C, D, E, K and theirderivatives such as vitamin A palmitate and pro-vitamins, e.g. (i.e.,panthenol (pro vitamin B5) and panthenol triacetate) and mixturesthereof.

Examples of suitable antimicrobial agents nonexclusively includebacitracin, erythromycin, neomycin, tetracycline, chlortetracycline,benzethonium chloride, phenol, benzyl peroxide, metal salts or ions suchas silver and its salts and mixtures thereof.

Examples of suitable skin emollients and skin moisturizersnonexclusively include mineral oil, lanolin, vegetable oils, isostearylisostearate, glyceryl laurate, methyl gluceth-10, methyl gluceth-20chitosan, and mixtures thereof.

An example of a suitable hair softener nonexclusively includes siliconecompounds, such as those that are either non-volatile or volatile andthose that are water soluble or water insoluble. Examples of suitablesilicones include organo-substituted polysiloxanes, which are eitherlinear or cyclic polymers of monomeric silicone/oxygen monomers andwhich nonexclusively include cetyl dimethicone; cetyl triethylammoniumdimethicone copolyol phthalate; cyclomethicone; dimethicone copolyol;dimethicone copolyol lactate; hydrolyzed soy protein/dimethiconecopolyol acetate; silicone quaternium 13; stearalkonium dimethiconecopolyol phthalate; stearamidopropyl dimethicone; and mixtures thereof.

Examples of sunscreens, nonexclusively include benzophenones, bornelone,butyl paba, cinnamidopropyl trimethyl ammonium chloride, disodiumdistyrylbiphenyl disulfonate, PABA and its derivatives (such as octyldimethyl PABA, butyl methoxydibenzoylmethane, isoamyl methoxycinnamate,methyl benzilidene camphor, octyl triazole, octyl methoxycinnamate,oxybenzone, octocrylene, octyl salicylate, homosalate,phenylbenzimidazole sulfonic acid, ethyl hydroxypropyl aminobenzoate,menthyl anthranilate, aminobenzoic acid, cinoxate, diethanolaminemethoxycinnamate, glyceryl aminobenzoate, titanium dioxide, zinc oxide,oxybenzone, Padimate O, red petrolatum, MEXORYL S and SX, TINOSORB M andS, and mixtures thereof.

Examples of skin lightening agents nonexclusively include hydroquinone,catechol and its derivatives, ascorbic acid and its derivatives, andmixtures thereof.

Examples of suitable insecticides (including insect repellents,anti-scabies and anti-lice treatments) nonexclusively includepermethrin, pyrethrin, piperonyl butoxide, imidacloprid, N,N-diethyltoluamide, which refers to the material containing predominantly themeta isomer, i.e., N,N-diethyl-m-toluamide, which is also known as DEET,natural or synthetic pyrethroids, whereby the natural pyrethroids arecontained in pyrethrum, the extract of the ground flowers ofChrysanthemum cinerariaefolium or C coccineum; and mixtures thereof.Within the structure of Formula III. are ethyl3-(N-butylacetamido)propionate, wherein R7 is a CH3 group, R5 is ann-butyl group, R6 is H, K is COOR8 and R8 is ethyl, which is availablecommercially from Merck KGaA of Darmstadt, Germany under the name,“Insect Repellent 3535.”

Examples of an anti-fungal for foot preparations nonexclusively includetolnaftate and myconozole.

Examples of suitable depilating agents nonexclusively include calciumthioglycolate, magnesium thioglycolate, potassium thioglycolate,strontium thioglycolate, and mixtures thereof.

Examples of suitable analgesics such as external analgesics and localanesthetics nonexclusively include benzocaine, dibucaine, benzylalcohol, camphor, capsaicin, capsicum, capsicum oleoresin, juniper tar,menthol, methyl nicotinate, methyl salicylate, phenol, resorcinol,turpentine oil, and mixtures thereof.

Examples of suitable antiperspirants and deodorants nonexclusivelyinclude aluminium chlorohydrates, aluminium zirconium chlorohydrates,and mixtures thereof.

Examples of suitable counterirritants nonexclusively include camphor,menthol, methyl salicylate, peppermint and clove oils, ichtammol, andmixtures thereof.

An example of a suitable inflammation inhibitor nonexclusively includeshydrocortisone, Fragaria vesca, Matricaria chamomilla, and Salviaofficinalis.

Examples of suitable anaesthetic ingredients nonexclusively include thebenzocaine, pramoxine hydrochloride, lidocaine, betacaine and mixturesthereof; antiseptics such as benzethonium chloride; astringents such aszinc oxide, bismuth subgallate, balsam Peru, and mixtures thereof; skinprotectants such as zinc oxide, silicone oils, petrolatum, cod liveroil, vegetable oil, and mixtures thereof.

Examples of such suitable benefits agents effective in the treatment ofdandruff, seborrheic dermatitis, and psoriasis, as well as the symptomsassociated therewith nonexclusively include zinc pyrithione, anthralin,shale oil and derivatives thereof such as sulfonated shale oil, seleniumsulfide, sulfur; salicylic acid; coal tar; povidone-iodine, imidazolessuch as ketoconazole, dichlorophenyl imidazolodioxalan (“elubiol”),clotrimazole, itraconazole, miconazole, climbazole, tioconazole,sulconazole, butoconazole, fluconazole, miconazole nitrate and anypossible stereo isomers and derivatives thereof; piroctone olamine(Octopirox); ciclopirox olamine; anti-psoriasis agents such as vitamin Danalogs, e.g. calcipotriol, calcitriol, and tacaleitrol; vitamin Aanalogs such as esters of vitamin A, e.g. vitamin A palmitate andvitamin A acetate, retinyl propionate, retinaldehyde, retinol, andretinoic acid; corticosteroids such as hydrocortisone, clobetasone,butyrate, clobetasol propionate menthol, pramoxine hydrochloride, andmixtures thereof.

Examples of benefit agents suitable for treating hair loss include, butare not limited to potassium channel openers or peripheral vasodilatorssuch as minoxidil, diazoxide, and compounds such asN*-cyano-N-(tert-pentyl)-N′-3-pyridinyl-guanidine (“P-1075”); sawpalmetto extract, vitamins, such as vitamin E and vitamin C, andderivatives thereof such as vitamin E acetate and vitamin C palmitate;hormones, such as erythropoietin, prostaglandins, such as prostaglandinEI and prostaglandin F2-alpha; fatty acids, such as oleic acid;diruretics such as spironolactone; heat shock proteins (‘HSP”), such asHSP 27 and HSP 72; calcium channel blockers, such as verapamil HCL,nifedipine, and diltiazemamiloride; immunosuppressant drugs, such ascyclosporin and Fk-506; 5 alpha-reductase inhibitors such asfinasteride; growth factors such as, EGF, IGF and FGF; transforminggrowth factor beta; tumor necrosis factor; non-steroidalanti-inflammatory agents such as benoxaprofen; retinoids such as retinaland tretinoin; cytokines, such as IL-6, IL-1 alpha, and IL-1 beta; celladhesion molecules such as ICAM, glucorcorticoids such as betametasone;botanical extracts such as aloe, clove, ginseng, rehmannia, swertia,sweet orange, zanthoxylum, Serenoa repens (saw palmetto), Hypoxisrooperi, stinging nettle, pumpkin seeds, and rye pollen; other botanicalextracts including sandlewood, red beet root, chrysanthemum, rosemary,burdock root and other hair growth promoter activators; homeopathicagents such as Kalium Phosphoricum D2, Azadirachta indica D2, andJoborandi DI, genes for cytokines, growth factors, and male-patteredbaldness; antifungals such as ketoconazole and elubiol; antibiotics suchas streptomycin; proteins inhibitors such as cycloheximide;acetazolamide; benoxaprofen; cortisone; diltiazem; hexachlorobenzene;hydantoin; nifedipine; penicillamine; phenothaiazines; pinacidil;psoralens, verapamil; zidovudine; alpha-glucosylated rutin having atleast one of the following rutins: quercetin, isoquercitrin, hespeddin,naringin, and methylhesperidin, and flavonoids and transglycosidatedderivatives thereof; and mixtures thereof.

Examples of benefit agents suitable for use in inhibiting hair growthinclude: serine proteases such as trypsin; vitamins such asalpha-tocophenol (vitamin E) and derivatives thereof such as tocophenolacetate and tocophenol palmitate; antineoplastic agents, such asdoxorubicin, cyclophosphamide, chlormethine, methotrexate, fluorouracil,vincristine, daunorubicin, bleomycin and hydroxycarbamide;anticoagulants, such as heparin, heparinoids, coumaerins, detran andindandiones; antithyroid drugs, such as iodine, thiouracils andcarbimazole; lithium and lithium carbonate; interferons, such asinterferon alpha, interferon alpha-2a and interferon alpha-2b;retinoids, such as retinol (vitamin A), isotretinoin: glucocorticoidssuch as betamethasone, and dexamethosone; antihyperlipidaemic drugs,such as triparanol and clofibrate; thallium; mercury; albendazole;allopurinol; amiodarone; amphetamines; androgens; bromocriptine;butyrophenones; carbamazepine; cholestyramine; cimetidine; clofibrate;danazol; desipramine; dixyrazine; ethambutol; etionamide; fluoxetine;gentamicin, gold salts; hydantoins; ibuprofen; impramine;immunoglobulins; indandiones; indomethacin; intraconazole; levadopa;maprotiline; methysergide; metoprolol; metyrapone; nadolol; nicotinicacid; potassium thiocyanate; propranolol; pyridostimine; salicylates;sulfasalazine; terfenadine; thiamphenicol; thiouracils; trimethadione;troparanol; valproic acid; and mixtures thereof.

Examples of suitable anti-aging agents include, but are not limited toinorganic sunscreens such as titanium dioxide and zinc oxide; organicsunscreens such as octyl-methoxy cinnamates and derivatives thereof;retinoids; copper containing peptides; vitamins such as vitamin E,vitamin A, vitamin C, vitamin B, and derivatives thereof such as vitaminE acetate, vitamin C palmitate, and the like; antioxidants includingbeta carotene, alpha hydroxy acids such as glycolic acid, citric acid,lactic acid, malic acid, mandelic acid, ascorbic acid,alpha-hydroxybutyric acid, alpha-hydroxyisobutyric acid,alpha-hydroxyisocaproic acid, atrrolactic acid, alpha-hydroxyisovalericacid, ethyl pyruvate, galacturonic acid, glucoheptonic acid,glucoheptono 1,4-lactone, gluconic acid, gluconolactone, glucuronicacid, glucuronolactone, glycolic acid, isopropyl pyruvate, methylpyruvate, mucic acid, pyruvic acid, saccharic acid, saccade acid1,4-lactone, tartaric acid, and tartronic acid; beta hydroxy acids suchas beta-hydroxybutyric acid, beta-phenyl-lactic acid, beta-phenylpyruvicacid; polyphenolics; botanical extracts such as green tea, soy products,milk thistle, algae, aloe, angelica, bitter orange, coffee, goldthread,grapefruit, hoellen, honeysuckle, Job's tears, lithospermum, mulberry,peony, puerarua, nice, safflower, and mixtures thereof.

Examples of suitable anti-acne agents include, but are not limited totopical retinoids (tretinoin, isotretinoin, motretinide, adapalene,tazarotene, azelaic acid, retinol); salicylic acid; benzoyl peroxide;resorcinol; antibiotics such as tetracycline and isomers thereof,erythromycin, and the anti-inflammatory agents such as ibuprofen,naproxen, hetprofen; botanical extracts such as alnus, arnica, artemisiacapillaris, asiasarum root, birrh, calendula, chamomile, cnidium,comfrey, fennel, galla rhois, hawthorn, houttuynia, hypericum, jujube,kiwi, licorice, magnolia, olive, peppermint, philodendron, salvia, sasaalbo-marginate; imidazoles such as ketoconazole and elubiol.

Examples of suitable depigmentation agents include, but are not limitedto soy products, retinoids such as retinol; Kojic acid and itsderivatives such as, for example, kojic dipalmitate; hydroquinone and itderivatives such as arbutin; transexamic acid; vitamins such as niacin,vitamin C and its derivatives; azelaic acid; placertia; licorice;extracts such as chamomile and green tea, and mixtures thereof, withretinoids, Kojic acid, soy products, and hydroquinone being particularlysuitable examples.

Examples of suitable anti-hemorrhoidal products include, but are notlimited to anesthetics such as benzocaine, pramoxine hydrochloride, andmixtures thereof; antiseptics such as benzethonium chloride; astringentssuch as zinc oxide, bismuth subgallate, balsam Peru, and mixturesthereof; skin protectants such as cod liver oil, vegetable oil, andmixtures thereof.

Examples of vasodilators include, but are not limited to minoxidil,diazoxide, and compounds such asN*-cyano-N-(tert-pentyl)-N′-3-pyridinyl-guanidine (“P-1075”).

Examples of suitable shine-control agents include, but are not limitedto hydrated silica, kaolin, and bentonite. Examples of suitableanti-histamines include, but are not limited to diphenhydramine HCl.

Examples of suitable antiinfectives include, but are not limited tobenzalkonium chloride, hexamidine, and hydrogen peroxide. Examples ofsuitable wound healing promoters include, but are not limited tochitosan and its derivatives. Examples of suitable poison ivy and poisonoak products include, but are not limited to bentonite, hydrocortisone,menthol, and lidocaine. Examples of burn products include, but are notlimited to benzocaine and lidocaine. Examples of suitable anti-diaperrash products include but are not limited to zinc oxide and petrolatum.Examples of suitable prickly heat products include, but are not limitedto zinc oxide. Examples of suitable sensates include, but are notlimited to menthol, fragrances, and capsaicin.

Benefit agents that may be particularly suitable for use with the shapedfilm product 100 include, DMAE, soy products, colloidal oatmeal,sulfonated shale oil, olive leaf, elubiol,6-(1-piperidinyl)-2,4-pyrimidinediamine-3-oxide, finasteride,ketoconazole, salicylic acid, zinc pyrithione, coal tar, benzoylperoxide, selenium sulfide, hydrocortisone, sulfur, menthol, pramoxinehydrochloride, tricetylmonium chloride, polyquaternium 10, panthenol,panthenol triacetate, vitamin A and derivatives thereof, vitamin B andderivatives thereof, vitamin C and derivatives thereof, vitamin D andderivatives thereof, vitamin E and derivatives thereof, vitamin K andderivatives thereof, keratin, lysine, arginine, hydrolyzed wheatproteins, copper containing compounds such as copper containing peptidesand copper salts, hydrolyzed silk proteins, octyl methoxycinnamate,oxybenzone, avobenzone, minoxidil, saw palmetto extract, titaniumdioxide, zinc dioxide, retinol, erthromycin, tretinoin, and mixturesthereof.

Benefit agents that may be of particularly suitable for use the shapedfilm product 100 include neo-collagen promoters (e.g. retinoids such asretinal and copper-containing peptides), skin firming agents (e.g.DMAE), and depigmenting agents (e.g. soy).

The amount of the benefit agent that may be used may vary dependingupon, for example, the ability of the benefit agent to penetrate throughthe skin or nail, the specific benefit agent chosen, the particularbenefit desired, the sensitivity of the user to the benefit agent, thehealth condition, age, and skin and/or nail condition of the user, andthe like. In sum, the benefit agent is used in a “safe and effectiveamount,” which is an amount that is high enough to deliver a desiredskin or nail benefit or to modify a certain condition to be treated, butis low enough to avoid serious side effects, at a reasonable risk tobenefit ratio within the scope of sound medical judgment.

The benefit agent may be formulated, mixed, or compounded with otheringredients into a composition (e.g. liquid, emulsion, cream, and thelike) wherein the other ingredients do not detract from thefunctionality of the benefit agent. A delivery agent that enhances theabsorption of the one or more benefit agents into the skin may beformulated with the benefit agent to fulfill this function. Suitabledelivery agents include, for example, sulfoxides, alcohols such asethanol; fatty acids such as, for example, linoleic acid or oleic acid,fatty esters such as, for example, may be produced from reacting aC3-C10 carboxylic acid with a C10-C20 fatty alcohol; a polyol, analkane, an amine, an amide, a turpene, a surfactant, a cyclodextrin orcombinations thereof among other agents known to the art to be suitablefor enhancing the penetration of various benefit agents through thestratum corneum into deeper layers of the skin.

The concentration of the benefit agent within the composition isvariable. Unless otherwise expressed herein, typically the benefit agentis present in the composition in an amount, based upon the total weightof the composition/system, from about 0.01 percent to about 20 percent,such as from about 0.01 percent to about 5 percent (e.g., from about0.01 percent to about 1 percent).

This composition that includes the benefit agent may also serve as acoupling composition as described previously and may include ingredientsthat enable the composition to possess one of these functions.

In addition to, or in place of one or more of the components describedabove, fragrances, flavors, sweeteners, coloring agents, pigments, dyesand the like may be added to the film-forming composition of the presentinvention.

What is claimed is:
 1. An apparatus for forming a shaped film productcomprising; a. a mask having an aperture corresponding to the desiredshaped film product; b. a mask support having a release-lined substratedisposed thereon, the mask support being arranged and configured tosupport the mask; c. a system for delivering a liquid film-formingcomposition to the mask aperture comprising a liquid film-formingcomposition reservoir in fluid communication with at least one pump todeliver the liquid film-forming composition to the mask aperture; a pumpcontroller to control the flow of the liquid film-forming composition,and a nozzle in partial sealing arrangement with the mask and having amachine direction dimension less than that of the mask aperture, thenozzle being arranged and configured to receive the liquid film-formingcomposition and to deliver it to the mask aperture, wherein a shapedfilm product is formed on the release-lined substrate and is removabletherefrom for use.
 2. The apparatus of claim 1 wherein the system fordelivering the liquid film-forming composition to the mask aperture isarranged and configured to deliver the liquid film-forming compositionto the mask aperture in a substantially laminar flow.